- Merck & Co. (Rahway, NJ)
- …and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead the implementation ... suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management activities. Lead the preparation of materials… more
- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Repligen (Hopkinton, IA)
- …in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office, including Word and Excel. MS Access ... OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality...actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document… more
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... manufacturer? If so, then this is the opportunity for you! The Lead Maintenance Technician is responsible for providing equipment troubleshooting and maintenance… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Merck & Co. (Rahway, NJ)
- …syringes, and complex drug delivery systems .Proven expertise in design controls , risk analysis, control strategies, design verification testing, and process ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Twist BioScience (South San Francisco, CA)
- …a proven ability to scale accounting operations, and the determination to lead the department through growth and continuous improvement.Position is Hybrid - Tuesday, ... support strategic initiatives by establishing the proper general ledger structure and controls for investments in new products and servicesEnsure proper oversight of… more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation,… more
- Novo Nordisk Inc. (Durham, NC)
- …in relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting,… more
- Aequor (Davie, FL)
- …:1. Electrical field degree with a minimum of 2 years working with electrical systems (24v - 480V) and utilities (HVAC, Boilers, water systems , cooling towers, ... The position will function as a subject matter expert for electrical systems and installations.Also in equipment maintenance, trouble shooting and repair. It… more
- Aequor (Thousand Oaks, CA)
- …a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected ... Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing security… more
- Repligen (Clifton Park, NY)
- …the tools and techniques of Lean Manufacturing and incorporate it into the culture. Lead the implementation of the Repligen Performance System (RPS) throughout ... linear motion, cartesian motion (ie, pick & place, measurement, load, and unload). Controls - vision systems , PLC, sensors, pneumatics, hydraulics, electronics,… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process, Multiple ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe purpose of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In ... addition, this role will lead the forecasting process supporting the Business Development team...established Revenue forecasting process, puts into effect governance and controls steps to safeguard the integrity of the process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focus, for supporting and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to patients. This role ... role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from...and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... for performance, member experience, and operational efficiency.Risk & ComplianceMaintain strong controls and procedures to comply with all applicable laws and… more
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